RELIABILITY OF HOMEOPATHIC AN ESSENTIAL REQUIREMENT Behind every medicine, there is a patient who trusts us. Every Boiron partner is guided by this statement. It’s what we pride ourselves on.

— 3 — We know your requirements. We share them.

Doctors, pharmacists, laboratories: each in our own way, we contribute to the health of patients. As a laboratory, our commitment, first and foremost, is to guarantee that our homeopathic are reliable and of high-quality. From this perspective, having our own equipment to produce all of our medicines ourselves demonstrates our willingness to master the manufacturing process in its entirety. Constantly striving to do better, the 141 Boiron pharmacists and the entire production team monitor the quality of our medicines on a daily basis. With rigour and professionalism, they focus on promoting excellence by routinely combining tradition and innovation.

Our commitment: to allow you to rest assured that Boiron homeopathic medicines are reliable as well as beneficial to your practice and to the health of your patients.

Jean-Christophe Bayssat, Deputy General Manager, Responsible Pharmacist

— 3 — GUARANTEEING THE QUALITY OF THE RAW MATERIALS MASTERING THE SPECIFIC FEATURES OF A UNIQUE MEDICINE Ensuring consistent quality of the substances used E Our homeopathic medicines are produced from For instance, our plants undergo a triple control Strains of varied substances of varying origin using a dynamic screening. origin dilution process. Organoleptic: to ensure that the batch received is healthy To identify and collect these raw materials, (no disease or aphids) and clean (free from Boiron surrounds itself with qualified foreign matter). professionals with preference given to regional Botanical: 53 % partnerships to promote proximity. Such is the to confirm the identification of the species. of plant origin case with certain venoms collected manually by Physico-chemical: the world leading expert (in la Drôme, France), to detect the presence of components required who breeds snakes for therapeutic or research by the Pharmacopoeia and to measure its key purposes. components. 33 % In regards to the harvesting of plants, our partners For the control of certain other raw materials, of mineral and are regularly audited in terms of the harvesting we work closely with experts specialising in their chemical origin location and compliance with Boiron field: analysis of the sea water used in oyster specifications. farming for harvesting of calcium carbonate, Upon arrival at the laboratory, our raw materials X-ray diffraction for certain minerals are subjected to strict quality controls. (e.g.: Palladium metallicum). 14 % of animal origin

100 % “ made in Boiron ” granules and globules

To master the entire manufacturing process, Boiron decided to carry out the production of granules and globules - specific to homeopathic medicines.

We have used a patented process for this The same expertise is applied to other purpose since 1972. Boiron’s granules and medicine formats which we produce such globules contain 85% sucrose and 15% lactose. as ointments, tablets, eye drops etc. E The presence of lactose boosts the quality of our medicines since it enables: Thanks to the pellet dispenser, an increased porosity of the granules and the Boiron tubes, designed specifically for days to produce globules, our medicines, provide patients with a Boiron granule an improved distribution and retention of easy-of-use, guaranteed delivery of the 16 the homeopathic dilution. right dose. — 4 — — 5 — GUARANTEEING THE QUALITY OF THE RAW MATERIALS MASTERING THE SPECIFIC FEATURES OF A UNIQUE MEDICINE

With a rigorous scientific approach, – the doctor behind the advent of - precisely defined the various phases in the manufacturing process. Today, the quality of homeopathic medicines still depends on compliance with this unique process, which we master every step of the way.

Traditional homeopathic dilution with the help of high-technology Providing reliable homeopathic

Each dilution is prepared according to traditional medicines to healthcare methods, listed in the French Pharmacopoeia since 1965 and still in use today. professionals around the world: Homeopathic dilution is carried out in our laboratories in a laminar flow clean air enclosure, that’s our craft. which filters ambient air. A central air system controls pressure, temperature and hygrometry.

Triple medication: a Boiron innovation that Automated succussion to became a standard procedure guarantee reproducibility In 1961, Jean Boiron developed and patented Succussion, a vital step in the preparation a triple medication process guaranteeing of , is carried out homogeneous medication of the active mechanically, using a specialised machine ingredient down to the core of the granule. called a “succussor.” Originally carried out by hand, triple medication has This process guarantees reproducibility in now become standardised to guarantee the quality terms of frequency, duration and amplitude of the various stages: of the succussing: succussed 150 times over - micro-spraying using glass nozzles calibrated to 7 seconds. the nearest micron, This ensures that the succussion is perfectly - homogenisation optimised by controlling the angle identical from one dilution to the next. of inclination and rotation speed of the turbines, - Filtered Air drying.

— 4 — — 5 — INNOVATION SERVING TRADITION MAKING WAY FOR HOMEOPATHIC MEDICINE IN THE FUTURE A modern-day medicine faithful to traditional processes E Ever since our inception, our mission has been To achieve this, we have developed our own to improve technical manufacturing conditions industrial tool, designed specifically to respond to ensure the large-scale production of a to the unique manufacturing process adopted reproducible and reliable homeopathic medicine. for homeopathic medicines: e.g. succussion, triple medication, granules and globules 460 Our teams work on a daily basis to strike manufactured onsite. A strong workforce a balance between respect for traditional This industrial process ensures that our involved in procedures and constant technological medicines are perfectly reproducible with the producing our innovation. same quality of product available across the world. medicines

Quality control: a constant requirement

Within our teams, 60 staff members focus on quality control across the manufacturing process. We have our own specialised laboratories. E Chemistry laboratory The Boiron production sites are Approximately 4,000 analyses regularly inspected by the French Approximately each year: liquid chromatography, National Agency for Medicines and gas chromatography, (UV and IR) Health Products Safety (ANSM). spectrophotometry, atomic We are also audited by the absorption spectrometry, etc. authorities in countries where Bacteriology laboratory our medicines are available: Around 23,000 control procedures are recently Brazil (ANVISA, Agência 30,000 performed each year on raw materials. Nacional de Vigilância Sanitária, control procedures are Botanical laboratory in 2011), the United States (FDA, carried out each year by Over 3,000 controls are carried out Food and Drug Administration, our teams throughout the every year, from receipt onwards, in 2015), Kazakhstan (National manufacturing process by a team of pharmacists, Centre for Drug Expertise, chemists and botanists. in 2014).

— 6 — — 7 — INNOVATION SERVING TRADITION MAKING WAY FOR HOMEOPATHIC MEDICINE IN THE FUTURE

We are dedicated to recognising Preserving the environment the merits of homeopathy and and safeguarding the future safeguarding its future of species

In 1897, the Homeopathic Pharmacopoeia was published for Respect for local ecosystems and natural resources is at the first time in the United States. It was recognised by the the heart of our procurement practices. American Health Authorities in 1938. For plant species, we get our supplies from roughly thirty In France, thanks to the work of Jean Boiron, homeopathy was botanical experts who share the same objectives: included in the French Pharmacopoeia in 1965, before being to perpetuate plant resources, officially recognised by the European Pharmacopoeia in 1995. to optimise the traceability of plant substances, to preserve the environment and biotopes. Ever since our inception, our mission has been to ensure that our medicines are registered and recognised in many Boiron complies with the good practices of plant harvesting countries, giving healthcare professionals the widest recommended by the World Health Organisation (WHO) possible choice of medicines. and has its own harvesting specification. This specification This development has been achieved in accordance with: also applies to the cultivation of species that do not grow in pharmaceutical regulations, the wild (Calendula officinalis) or species threatened by requirements in terms of the quality and reproducibility harvesting due to the quantities used (Valeriana officinalis). of the manufacturing process.

Recognition of homeopathic medicine created by Jean and Henri Boiron: this is our heritage. To continue this work, that’s our ambition.

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Mai 2016 - IMP.1CYW